Height-based Formula for Predicting the Insertion Depth of Left-sided Double and the Role of Fiberoptic Bronchoscopy

• Sponsor: King Saud University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04449770
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Anticipated Duration (Months): 22
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief Summary

The use of height based formula to predict insertion depth of left-sided double lumen tube in thoracic surgery is now well established. The investigators have developed a formula to be used and published recently. The investigators verified the formula with the use of FOB. This observational study we are going to use with FOB checking if needed.

Condition or Disease	Intervention/Treatment	Phase
Thoracic Anesthesia	Device: double lumen tube

Detailed Description

The use of a height-based formula to predict the insertion depth of left-sided double-lumen tubes in thoracic surgery is now well established. The investigators have developed a formula to be used and published recently. The investigators verified the formula with the use of FOB. This observational study will use FOB checking if needed.

Our hypothesis is that DLT can insert without the use of FOB in most of the cases. That doesn't mean FOB is less required.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 70 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Study on the Use of an Established Novel Height-based Formula for Predicting the Insertion Depth of Left-sided Double and the Role of Fiberoptic Bronchoscopy
• Anticipated Study Start Date: Aug 1, 2020
• Anticipated Primary Completion Date: Jun 1, 2022
• Anticipated Study Completion Date: Jun 1, 2022

Outcome Measures

Primary Outcome Measures

1. correct position of DLT with proper lung deflation without use of FOB [during surgical time]

   proper lung deflation, surgeon satisfaction

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• patients whose procedure required placement of an LDLT

Exclusion Criteria:

• patients with intraluminal bronchial lesions and patients with a difficult airway.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	King Saud University	Riyadh		Saudi Arabia	11462

Sponsors and Collaborators

• King Saud University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: A.Eldawlatly, professor, King Saud University
• ClinicalTrials.gov Identifier: NCT04449770
• Other Study ID Numbers: E-18-3064/IRB 06.05.2018
• First Posted: Jun 29, 2020
• Last Update Posted: Jul 10, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by A.Eldawlatly, professor, King Saud University: Thoracic anesthesia; Double lumen tube; Height based formula

Study Results

No Results Posted as of Jul 10, 2020